510(k) Report

Devices descending from K041724

41 later devices reach Compass M10 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+1K061405Apnealink, Model 22302Resmed Germany, Inc.200630—
+2K242290DormoTech NLabDormotech Medical, Ltd.20250—
+2K143272ApneaLink AirResmed Germany, Inc.20157—
+2K124062QDC-Pro, and Nox-RipNox Medical20133—
+2K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+2K070263ApnealinkResmed Germany, Inc.200729—
+3K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+3K163665MATRx plusZephyr Sleep Technologies20173—
+3K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+3K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+3K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+4K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+4K242447Falcon HSTCompumedics Limited20250—
+4K192624ApneaTrakCadwell Industries, Inc.20200—
+4K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+4K181996MATRx PlusZephyr Sleep Technologies20182—
+4K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+4K140124S9 EloueraResmed Corp20148—
+4K132371Easycare OnlineResmed, Ltd.20138—
+4K131932Apnealink ProResmed Germany, Inc.20138—
+5K261360EasyCare Tx 2Resmed Corp20260—
+5K251889myAirResmed Corp20260—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K191925MATRx PlusZephyr Sleep Technologies20191—
+5K160836Menai SystemResmed, Ltd.20166—
+5K152356SapphireRespironics, Inc.20164—
+5K151901AirViewResmed, Ltd.20151—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K242485EveryWareBreas Medical AB20250—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K200565GalapogosResmed Corp20213—
+6K200695MATRx plusZephyr Sleep Technologies20200—
+6K183226Care Orchestrator EssenceRespironics, Inc.20190—
+6K181053Care OrchestratorRespironics, Inc.20191—
+7K241216myAirResmed Corp20242—
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+8K250624myAirResmed Corp20251—
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—